Kura Oncology Combination Therapy Shows Promise for Refractory Kidney Cancer

Darlifarnib plus cabozantinib demonstrates robust activity in patients with clear cell renal cell carcinoma previously treated with cabozantinib

Apr. 17, 2026 at 10:23am

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A ghostly, translucent X-ray photograph revealing the internal structures of a kidney tumor as glowing lines against a dark background, conceptually illustrating the advanced imaging techniques used to study this new cancer treatment approach.An X-ray image of a kidney tumor highlights the potential of a novel combination therapy to overcome resistance and resensitize advanced renal cell carcinoma to targeted treatment.Oklahoma City Today

Kura Oncology, Inc. announced new preliminary data from a subset analysis of patients with clear cell renal cell carcinoma (ccRCC) previously treated with cabozantinib in the ongoing FIT-001 clinical trial of darlifarnib in combination with cabozantinib. The analysis found the combination demonstrated robust antitumor activity and a manageable safety profile in this heavily pretreated population.

Why it matters

Patients with advanced ccRCC whose disease progresses on cabozantinib have limited treatment options, so these findings suggest the darlifarnib-cabozantinib combination may offer meaningful clinical benefit in this refractory setting or for patients with disease progression after prior therapy.

The details

The analysis evaluated 16 patients with ccRCC who had previously received cabozantinib. The combination showed an objective response rate of 44% and a disease control rate of 94%, with tumor shrinkage observed in 75% of patients. Responses were seen in heavily pretreated patients, including those whose best prior response to cabozantinib was stable disease. Treatment durations ranged from 8 to 56 weeks, with six patients remaining on therapy at data cutoff.

  • The data was presented at the 2026 International Kidney Cancer Symposium (IKCS): Europe in Paris, France.
  • Kura will host a virtual investor event on April 17, 2026 to discuss the findings.

The players

Kura Oncology, Inc.

A biopharmaceutical company focused on precision medicines for the treatment of cancer.

Adanma Ayanambakkam, M.D., M.S.

Assistant Professor of Hematology Oncology and Director of Genitourinary Medical Oncology Research at the Stephenson Cancer Center, University of Oklahoma Health Sciences Center.

Mollie Leoni, M.D.

Chief Medical Officer of Kura Oncology.

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What they’re saying

“Patients with advanced ccRCC whose disease progresses on cabozantinib have limited treatment options. The tumor shrinkage and high disease control rate observed with darlifarnib in combination with cabozantinib suggest this approach may offer meaningful clinical benefit in a refractory setting or in patients with disease progression after therapy.”

— Adanma Ayanambakkam, M.D., M.S., Assistant Professor of Hematology Oncology and Director of Genitourinary Medical Oncology Research, Stephenson Cancer Center, University of Oklahoma Health Sciences Center

“These data highlight the potential of darlifarnib to overcome resistance to prior cabozantinib and enhance the activity of VEGF TKIs in patients with advanced RCC. We are highly encouraged by these results and are committed to advancing this combination to evaluate further its potential to deliver meaningful benefit for RCC patients.”

— Mollie Leoni, M.D., Chief Medical Officer of Kura Oncology

What’s next

The FIT-001 study is advancing into Phase 1b dose expansion to assess an optimal biologically active dose for the darlifarnib-cabozantinib combination.

The takeaway

This combination therapy shows promise for treating patients with advanced renal cell carcinoma who have progressed on prior cabozantinib, a population with limited treatment options. The robust antitumor activity and manageable safety profile warrant further investigation to evaluate the potential of this approach to deliver meaningful clinical benefit.